Impact of Acute Leg Cycling at Various Intensities on RLS Severity in Persons With MS

NCT03849001 | Withdrawn

• 1 other identifier: IRB-300002951
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the impact of acute leg cycling conditions at three different intensities versus a control condition condition on symptoms of restless legs syndrome (RLS) in persons with multiple sclerosis (MS). This study includes a proposed sample of 24 participants diagnosed with both MS and RLS that will complete four sessions of supervised exercise or rest conditions in the lab, one session per week, over the course of four weeks.

Conditions

Multiple Sclerosis; Restless Legs Syndrome

Keywords

Exercise

Outcome Measures

Primary Outcomes (8)

• Restless Legs Syndrome Severity as measured by the Suggested Immobilization Test (SIT)

  Participants will be reclined at a 45 degree angle on a padded treatment table with legs outstretched and will be instructed to avoid any voluntary movement of the legs for the 60 minute duration of the test. Periodic limb movements during wakefulness (PLMW) will be quantified using two accelerometers and self-reported severity of leg discomfort during the SIT will be assessed using a visual analog scale (VAS) that ranges from 0 (no discomfort) to 100 (extreme discomfort) every five minutes during the test. The SIT will be completed immediately before the light exercise condition to capture pre-exercise RLS severity.

  10 minutes pre-exercise condition

• Restless Legs Syndrome Severity as measured by the Suggested Immobilization Test (SIT)

  Participants will be reclined at a 45 degree angle on a padded treatment table with legs outstretched and will be instructed to avoid any voluntary movement of the legs for the 60 minute duration of the test. Periodic limb movements during wakefulness (PLMW) will be quantified using two accelerometers and self-reported severity of leg discomfort during the SIT will be assessed using a visual analog scale (VAS) that ranges from 0 (no discomfort) to 100 (extreme discomfort) every five minutes during the test. The SIT will be completed immediately after the light exercise condition to capture post-exercise RLS severity.

  10 minutes post-exercise condition

• Restless Legs Syndrome Severity as measured by the Suggested Immobilization Test (SIT)

  Participants will be reclined at a 45 degree angle on a padded treatment table with legs outstretched and will be instructed to avoid any voluntary movement of the legs for the 60 minute duration of the test. Periodic limb movements during wakefulness (PLMW) will be quantified using two accelerometers and self-reported severity of leg discomfort during the SIT will be assessed using a visual analog scale (VAS) that ranges from 0 (no discomfort) to 100 (extreme discomfort) every five minutes during the test. The SIT will be completed immediately before the moderate exercise condition to capture pre-exercise RLS severity.

  10 minutes pre-exercise condition

• Restless Legs Syndrome Severity as measured by the Suggested Immobilization Test (SIT)

  Participants will be reclined at a 45 degree angle on a padded treatment table with legs outstretched and will be instructed to avoid any voluntary movement of the legs for the 60 minute duration of the test. Periodic limb movements during wakefulness (PLMW) will be quantified using two accelerometers and self-reported severity of leg discomfort during the SIT will be assessed using a visual analog scale (VAS) that ranges from 0 (no discomfort) to 100 (extreme discomfort) every five minutes during the test. The SIT will be completed immediately after the moderate exercise condition to capture post-exercise RLS severity.

  10 minutes post-exercise condition

• Restless Legs Syndrome Severity as measured by the Suggested Immobilization Test (SIT)

  Participants will be reclined at a 45 degree angle on a padded treatment table with legs outstretched and will be instructed to avoid any voluntary movement of the legs for the 60 minute duration of the test. Periodic limb movements during wakefulness (PLMW) will be quantified using two accelerometers and self-reported severity of leg discomfort during the SIT will be assessed using a visual analog scale (VAS) that ranges from 0 (no discomfort) to 100 (extreme discomfort) every five minutes during the test. The SIT will be completed immediately before the vigorous exercise condition to capture pre-exercise RLS severity.

  10 minutes pre-exercise condition

• Restless Legs Syndrome Severity as measured by the Suggested Immobilization Test (SIT)

  Participants will be reclined at a 45 degree angle on a padded treatment table with legs outstretched and will be instructed to avoid any voluntary movement of the legs for the 60 minute duration of the test. Periodic limb movements during wakefulness (PLMW) will be quantified using two accelerometers and self-reported severity of leg discomfort during the SIT will be assessed using a visual analog scale (VAS) that ranges from 0 (no discomfort) to 100 (extreme discomfort) every five minutes during the test. The SIT will be completed immediately after the vigorous exercise condition to capture post-exercise RLS severity.

  10 minutes post-exercise condition

• Restless Legs Syndrome Severity as measured by the Suggested Immobilization Test (SIT)

  Participants will be reclined at a 45 degree angle on a padded treatment table with legs outstretched and will be instructed to avoid any voluntary movement of the legs for the 60 minute duration of the test. Periodic limb movements during wakefulness (PLMW) will be quantified using two accelerometers and self-reported severity of leg discomfort during the SIT will be assessed using a visual analog scale (VAS) that ranges from 0 (no discomfort) to 100 (extreme discomfort) every five minutes during the test. The SIT will be completed immediately before the seated, quiet rest condition to capture pre-rest RLS severity.

  10 minutes pre-rest (Control) condition

• Restless Legs Syndrome Severity as measured by the Suggested Immobilization Test (SIT)

  Participants will be reclined at a 45 degree angle on a padded treatment table with legs outstretched and will be instructed to avoid any voluntary movement of the legs for the 60 minute duration of the test. Periodic limb movements during wakefulness (PLMW) will be quantified using two accelerometers and self-reported severity of leg discomfort during the SIT will be assessed using a visual analog scale (VAS) that ranges from 0 (no discomfort) to 100 (extreme discomfort) every five minutes during the test. The SIT will be completed immediately after the seated, quiet rest condition to capture post-rest RLS severity.

  10 minutes post-rest (Control) condition

Secondary Outcomes (6)

• Restless Legs Syndrome Severity as measured by the International Restless Legs Syndrome Study Group Scale (IRLS)

  Baseline through screening

• Restless Legs Syndrome Severity as measured by the International Restless Legs Syndrome Study Group Scale (IRLS)

  Baseline through week 1

• Restless Legs Syndrome Severity as measured by the International Restless Legs Syndrome Study Group Scale (IRLS)

  week 1 through week 2

• Restless Legs Syndrome Severity as measured by the International Restless Legs Syndrome Study Group Scale (IRLS)

  week 2 through week 3

• Restless Legs Syndrome Severity as measured by the International Restless Legs Syndrome Study Group Scale (IRLS)

  week 3 through week 4

Study Arms (1)

Exercise Conditions

EXPERIMENTAL

Participants will undergo four "Exercise Conditions" (i.e., light intensity leg cycling, moderate intensity leg cycling, vigorous intensity leg cycling, and a seated, quiet rest) in a randomized, counterbalanced order.

Behavioral: Exercise Conditions

Interventions

Exercise Conditions BEHAVIORAL

Light Exercise

Exercise Conditions

Eligibility Criteria

• Age: 18 Years - 54 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• years of age
• Diagnosis of multiple sclerosis
• Has not experienced a relapse in the last 30 days
• Positive screening for restless legs syndrome
• Restless legs syndrome severity of moderate or greater
• Ambulatory with or without an aide

You may not qualify if:

• Moderate or high risk for undertaking strenuous or maximal exercise
• Diagnosis of: radiculopathy, peripheral edema, peripheral neuropathy, iron deficiency (i.e., anemia), renal disease, or diabetes

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

MeSH Terms

Conditions

Multiple Sclerosis; Restless Legs Syndrome; Motor Activity

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders; Behavior

Study Officials

• Robert W Motl, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: February 19, 2019
• First Posted: February 21, 2019
• Study Start: September 1, 2019
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: December 2, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share